美国政府周三宣布,已达成协议,如果证明安全有效,将获得至少1亿剂辉瑞冠状病毒候选疫苗。
美国卫生与公众服务部(HHS)和国防部宣布与辉瑞公司达成协议,在疫苗成功生产后,将大规模生产超过1亿剂疫苗。在收到首批1亿剂药物后,美国将向制药商支付19.5亿美元。
特朗普政府此前承诺免费获得COVID-19疫苗对于负担不起的美国人来说。
该协议还允许美国获得另外5亿剂疫苗。
2016年4月21日,美国制药商辉瑞公司的标志在加州拉霍亚市。
HHS国防部长阿历克斯·阿扎尔在一份声明中说:“通过‘曲速行动’,我们正在组建一个疫苗组合,以增加美国人民在今年年底至少拥有一种安全、有效疫苗的可能性。”
阿扎尔补充说:“根据临床试验的成功,今天的协议将使辉瑞和生物技术公司开发的大约1亿剂疫苗得以交付。”
辉瑞和德国合作伙伴生物技术公司将于本月晚些时候开始一项预期的2b/4阶段安全性和有效性试验。辉瑞早在2020年10月就在寻求监管审查,目标是到2020年底生产1亿剂,到2021年底生产13亿剂。
2020年5月4日,在巴尔的摩马里兰大学医学院进行的辉瑞公司冠状病毒19型疫苗临床试验中,第一名患者接受了注射。
辉瑞董事长兼首席执行官艾伯特布尔拉(Albert Bourla)博士在一份声明中表示:“我们一直致力于通过不懈努力,在创纪录的时间内开发和生产一种安全有效的疫苗,帮助结束这场全球健康危机,从而使不可能成为可能。”
布尔拉补充说,该公司“荣幸地成为这一努力的一部分,使美国人获得保护,免受这种致命的病毒。”
美国和德国目前正在进行疫苗的1/2阶段临床试验。
美国政府已经与其他疫苗生产商达成了类似的协议,包括莫德纳和牛津/阿斯利康。
US secures 100 million doses of Pfizer coronavirus vaccine candidate
The U.S. government announced Wednesday it has reached a deal to gain access to at least 100 million doses of a Pfizer coronavirus vaccine candidate if it proves to be safe and effective.
The Department of Health and Human Services (HHS) and the Department of Defense announced the agreement with Pfizer for the large-scale production of over 100 million doses following the vaccine's successful manufacture. Upon receipt of the first 100 million doses, the U.S. will pay the drugmaker $1.95 billion.
The Trump administration has previously committed tofree access for COVID-19 vaccinesfor Americans who can't afford it.
The agreement also allows the U.S. to acquire an additional 500 million doses.
The logo of U.S. drugmaker Pfizer is pictured here in La Jolla, California, April 21, 2016.
"Through Operation Warp Speed, we are assembling a portfolio of vaccines to increase the odds that the American people will have at least one safe, effective vaccine as soon as the end of this year," HHS Secretary Alex Azar said in a statement.
"Depending on success in clinical trials, today’s agreement will enable the delivery of approximately 100 million doses of vaccine being developed by Pfizer and BioNTech," Azar added.
Pfizer and German partner BioNTech are on track to begin an anticipated Phase 2b/4 safety and efficacy trial later this month. Pfizer is seeking regulatory review as early as October 2020 and aims to manufacture up to 100 million doses by the end of 2020 and up to 1.3 billion doses by the end of 2021.
The first patient enrolled in Pfizer's COVID-19 coronavirus vaccine clinical trial at the University of Maryland School of Medicine in Baltimore receives an injection, May 4, 2020.
"We’ve been committed to making the impossible possible by working tirelessly to develop and produce in record time a safe and effective vaccine to help bring an end to this global health crisis," Dr. Albert Bourla, Pfizer's chairman and CEO, said in a statement.
Bourla added the company is "honored to be a part of this effort to provide Americans access to protection from this deadly virus."
Phase 1/2 clinical trials are currently underway for the vaccines in the U.S. and Germany.
The U.S. government has similar agreements in place with other vaccine creators including Moderna and Oxford/AstraZenaca.